Here's a gem from today's Los Angeles Times:

Under pressure from the chemical industry, the Environmental Protection Agency has dismissed an outspoken scientist who chaired a federal panel responsible for helping the agency determine the dangers of a flame retardant widely used in electronic equipment.

Toxicologist Deborah Rice was appointed chair of an EPA scientific panel reviewing the chemical a year ago. Federal records show she was removed from the panel in August after the American Chemistry Council, the lobbying group for chemical manufacturers, complained to a top-ranking EPA official that she was biased.

Rice has outspokenly advocated for a ban on the flame retardant, deca, because she believes existing science proves the substance is harmful even at low levels. According to the LA Times, Rice is "an award-winning former EPA scientist who now works at the Maine Department of Health and Human Services."

So what is EPA's justification for her dismissal? "EPA officials removed Rice because of what they called 'the perception of a potential conflict of interest.' " What is the conflict here? The fact that she is a human?

Not only did EPA remove Rice from the panel, they also deleted her portions of an upcoming report regarding the chemical's safety. That could have major regulatory implications, as Andrew Schneider of The Seattle Post-Intelligencer reports:

EWG and two scientists in EPA with whom I spoke this morning, said the omission of Rice's comments from the review document could result in a significantly weaker safety standard for the chemical, which EPA intends to propose at the end of March 2008.

A proposed rule published in March gives EPA just enough time to gather comments and finalize the rule before the clock runs out on the Bush administration.

The Bush administration's Center for Medicare and Medicaid Services (CMS) has spent the better part of the past year pushing for changes at the federal level that would make it more difficult for states to administer government healthcare benefits.

One batch of regulations targets federal funding of state Medicaid programs. According to the Kaiser Family Foundation, "Each of the regulations is expected to reduce federal Medicaid spending by directly limiting the level of provider reimbursement, restricting the scope of services eligible for federal match and by limiting states' ability to finance their Medicaid programs."

In August, CMS proclaimed new guidance (a form of administrative government that is not subject to the standard public notice-and-comment period) that undermines the State Children's Health Insurance Program (SCHIP). CMS issued the new policy to reduce the chance state plans would extend SCHIP coverage to individuals who may be eligible for private coverage. Opponents of extending SCHIP eligibility often refer to this as "crowd-out."

CMS would accomplish this goal by prescribing a host of new requirements states would have to meet before receiving federal funding to extend benefits to children in need. Several states have already sued CMS over the guidance.

As BNA news service reports today, governors are angry about the changes. According to the article, Massachusetts governor Deval Patrick (D) said the SCHIP guidance would prevent certain children from being covered even though their parents would be eligible for other government provided healthcare. Washington governor Christine O. Gregorie, "said the SCHIP directive would interfere with its goal of providing health care coverage to all the state's children by 2010."

"Governors from both parties also urged Congress to stop several Medicaid regulations from being implemented, saying they would shift $13 billion in Medicaid spending over five years to the states at a time when states are facing an uncertain economy," according to the article.

The National Governors Association has written to Congress requesting a delay of the Medicaid regulations. Read the letter here.

The Food and Drug Administration is moving forward with a controversial new policy to allow pharmaceutical reps to market drugs for unapproved uses, despite objections from Congress and public health experts.

FDA doesn't just approve drugs, it approves drugs for specific uses. However, doctors can prescribe drugs for unapproved, or "off-label," uses.

Under a law that expired in 2006, pharmaceutical reps were legally able to distribute journal articles touting the benefits of off-label uses. But, according to the Associated Press, FDA maintained some regulatory oversight: "Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the articles' accuracy could be reviewed."

If FDA chooses to finalize this policy, which it published today as "proposed guidance," drug companies would be able to use journal articles to market off-label uses willy-nilly. The AP article continues, "Under the new proposal, drug companies don't have to submit articles."

Off-label use of drugs is big business. According to The Wall Street Journal, "[FDA] is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine."

According to Merrill Goozner at the GoozNews blog, the pharmaceutical lobby pushed for FDA to go forward with the policy which will be a boon for the industry:

So what was in today's proposed guidance? It pretty much gives industry everything it was looking for. It would allow drug salespersons to drop off article reprints as long as they came from a peer-reviewed journal that had a conflict-of-interest disclosure policy. Articles from industry-funded supplements would not be allowed…

Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research.

Rep. Henry Waxman (D-CA) caught wind of this policy last November and asked FDA to refrain from going forward. More on that here and here.

The Bush administration is pursuing or has achieved several policy goals that work to cut social support services by reducing federal funding for Medicaid programs. The Center for Medicare and Medicaid Services (CMS) has released all of these policies — three proposed rules, one interim final rule, and two final rules — in the past nine months.

Two recent reports (one by the Center for Budget and Policy Priorities and one by the Kaiser Family Foundation) link the policies together to show a uniform attack by the Bush administration on federal support of state Medicaid programs. From the Kaiser report:

The Administration views these regulatory changes as promoting the purposes of Medicaid by enhancing the integrity of the program. However, states argue that many of the regulations could limit flexibility in administering the program and could impede the ability of the Medicaid program to fulfill some of its critical roles in the health care system such as providing support to safety-net providers or providing long-term care supports in the least restrictive settings.

Basically, the new rules undermine Medicaid benefits by placing an increasing burden on the states. "Each of the regulations is expected to reduce federal Medicaid spending by directly limiting the level of provider reimbursement, restricting the scope of services eligible for federal match and by limiting states' ability to finance their Medicaid programs," according to the Kaiser report. By reducing federal spending, states would be forced to either cut benefits or pick up the slack financially.

Some of these rules represent efforts by the Bush administration to circumvent Congress. For example, one of the proposed rules would limit the ability of state governments to provide rehabilitation services (such as transitions to independent housing) for people with mental illnesses or developmental disabilities. According to the Kaiser report, the Bush administration proposed this limitation as a legislative provision in 2006, but Congress rejected it.

These are exactly the kind of administrative changes we should expect the Bush administration to pursue in its waning days of power. Confronted by a Democratically-controlled Congress and election-year politics, the administration will try to accomplish administratively what it cannot accomplish legislatively.

FDA's inability to ensure the safety of imported products is in the news again today. According to The New York Times, a plant in China, uninspected by FDA, is responsible for a contaminated ingredient in Heparin, a blood-thinning drug common in dialysis, heart surgeries and chronic care hospitals. At least four people have already died from using the drug.

Unlike some other dangerous import stories, this one isn't just about the inability of a federal agency to monitor imports; it's about flat-out negligence by FDA and by Heparin's maker, Baxter International. New York Times reporter Gardiner Harris has the story:

Public health officials noticed a problem with heparin supplies late last year when children undergoing dialysis at a Missouri hospital had severe allergic reactions. As officials investigated, they discovered hundreds of similar cases.

Baxter initially recalled some of the product, but the problems persisted.

The F.D.A. decided to allow Baxter to deliver heparin that it was in the midst of shipping for fear that a total recall would lead to an immediate and severe shortage of the drug. The F.D.A. cautioned doctors to use as little of the Baxter drug as possible and to infuse it into patients very slowly.

FDA and Baxter have known about the danger of Heparin for months, but, for most Americans, today will be the first they have heard of it.

Meanwhile, because FDA refused to stop Baxter shipments, users of Heparin were getting sick. According to an FDA press release, "About 350 adverse events associated with the Baxter product have been reported since the end of last year compared to less than 100 reports in 2007."

So instead of disseminating information that could have helped people, FDA chose to cover up the problem in the name of public health, even though hundreds were sickened and several died? Forgive Reg•Watch's cynicism, but could this be a case of FDA putting Baxter's corporate profits ahead of patients' safety?

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Big oil is knocking on the White House's door looking for sympathy over an EPA proposal to tighten the national standard for ozone, aka smog. On January 25, representatives from ExxonMobil and the American Petroleum Institute met behind closed doors with officials from EPA and the White House Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA). (Frank O'Donnell at the Blog for Clean Air has the full story.)

EPA's bid to tighten the ozone standard (from the current level of 0.084 ppm to somewhere between 0.070 and 0.075 ppm) has raised the ire of many industry representatives and anti-regulatory lobbyists like the National Association of Manufacturers. Detractors of the proposed ozone-reduction rule claim it would impose big costs on polluters and result in economic hardships for companies, employees, and consumers.

There are two big problems with that argument. First, the Clean Air Act prohibits EPA from considering economic impact when regulating ozone. The Supreme Court has upheld the prohibition. EPA must use the best available science to set a standard that will protect public health, regardless of compliance costs.

Second, those who claim big costs are relying on a deeply flawed cost-benefit analysis prepared by EPA and OIRA. Cost-benefit analysis in public policy is rarely helpful, and EPA's ozone rule is a good example of just how ridiculous it can be.

For one of the options EPA is considering (0.070 ppm), the cost-benefit analysis concluded potential costs of $20 billion or potential benefits of $23 billion. How is anyone supposed to draw a meaningful conclusion from a $43 billion range?

Furthermore, ozone exposure can shorten lives. Therefore, reducing ozone pollution can help people live better and live longer. How can anyone put a price tag on that?

For a more detailed discussion, read a recent opinion column from OMB Watch available at OurFuture.org: "How Bush Undermines Government Regulation"

(For a really detailed discussion, read OMB Watch's report, Polluted Logic: How EPA's ozone standard illustrates the flaws of cost-benefit analysis.)

Rep. John Dingell's Energy and Commerce Committee recently began an investigation into the use and safety of bisphenol-A, a chemical commonly found in a host of consumer products including plastic bottles. In a Feb. 6 article, ABC News reporter Justin Rood provides an update on exactly what the committee has been looking into.

According to the article, Dingell is particularly concerned with the work of scientific consultants. The article discusses one of those consultants, the Weinberg Group, which may be designing its scientific research in order to produce conclusions about bisphenol-A that downplay the negative effects of the chemical: "The Weinberg Group may play a role in arranging just the kinds of expert panels and scientific research the chemical industry points to in defense of its products, Dingell suggested."

The charges against the Weinberg Group are similar to those made against Sciences International, a contractor who the National Toxicology Program was paying to investigate the effects of bisphenol-A on reproductive health. (More on that here.) The Weinberg Group is not listed as a recipient of federal contracts or grants, according to FedSpending.org.

The scientific uncertainty surrounding bisphenol-A for years has prevented meaningful government intervention. Not only has use of the chemical gone unabated in consumer products, the public is in the dark as to which consumer products might contain bisphenol-A and what the ramifications might be.

At the very least, the public deserves to know the full set of facts about bisphenol-A and the companies who use it.

Yesterday, President Bush unveiled his FY 2009 budget proposal. There is plenty to be upset about in the proposal (as OMB Watch's Budget Blog has noted here.) Cuts in federal funding of environmental protection programs are among the most troubling.

Bush is proposing serious cuts at the U.S. Environmental Protection Agency — $330 million, or 4.4 percent. Sen. Barbara Boxer's Environment and Public Works Committee has prepared a list of EPA programs and research activities that will be cut if Bush gets his way. (See the list here.)

Of note, Bush is proposing cuts to EPA's endocrine disruptor research and prevention programs. Boxer's committee says the proposal, "Cuts $3.6 million (35%) from efforts to help protect people from endocrine disruptors, dangerous chemicals that can harm human health at very low levels by interfering with the body's hormone systems."

EPA's endocrine disruptor program is already woefully behind schedule. In 1996, Congress passed legislation mandating EPA assess the health impacts of endocrine disruptors. In the summer of 2007, EPA finally got around to step one of the process — releasing a list of chemicals to be tested and laying out the process for assessing risk. Critics assailed EPA's program as scientifically flawed and accused the agency of designing experiments to purposefully minimize findings of adverse effects. Budget cuts are not likely to move the research along or improve the quality of the risk assessment process.

One last thing, from a note at the bottom of the committee's press release:

These figures are based upon summary tables provided by EPA. Normally, EPA provides a detailed "Budget Justification" document with an explanation of all budget figures, but this year has failed to do so, undermining the transparency of the President's proposed budget.

Not surprisingly, the administration isn't just attempting to gut domestic programs, it's trying to do it without telling Congress or the public.